Zdrowie i gospodarka · 01/06/2001

Medical Devices Premarket Guidance: Reprocessing and Reuse of Single-Use Devices; Draft Guidance for Industry and FDA Staff; Availability

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Premarket Guidance: Reprocessing and Reuse of Single-Use Devices." This draft guidance document provides premarket guidance to the medical device industry, including third party and hospital reprocessors, and to Center for Devices and Radiological Health (CDRH) staff, who are responsible for the premarket evaluation of submissions for reprocessed single-use devices (SUDs) or related enforcement activities. This draft guidance is neither final nor is it in effect at this time.